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Johnson & Johnson Violated FDA Order to Halt Sales of Transvaginal Mesh
Date:6/27/2012

(PRWEB) June 27, 2012

In complete disregard of an order by the U.S. Food and Drug Administration (FDA) to stop marketing the Gynecare Prolift vaginal mesh implant, Johnson and Johnson (J&J) continued to sell the product for nine additional months. According to court records, in a letter dated August 24, 2007, the FDA advised J&J to halt the sales of the Gynecare Prolift until such time the agency determined whether the device was the “substantially equivalent” to other mesh products on the market. The letter clearly stated, “You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food Drug and Cosmetic Act.” Despite this warning, J&J continued to sell the mesh product until the FDA cleared the device in May 2008 after months of negotiations with J&J.

J&J initially began selling the Prolift in 2005. It failed to apply for application and approval from the FDA because it unilaterally determined its product was substantially similar to the Gynemesh product already approved by the FDA, according to Matthew Johnson, J&J spokesman. The FDA disagreed and required a new application be submitted. The company’s failure to initially heed FDA orders could prove costly. Currently there are more than 1,400 lawsuits pending against J&J by women injure
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